Full Press Release Details
by Robert S. Schwartz, Ph.D. January 3, 2026
On December 19, 2025, the FDA approved Amneal / mAbxience’s Boncresa™ / Oziltus™ (denosumab-mobz) as the nineth biosimilars of Amgen’s Prolia ® / Xgeva ® (denosumab) .
On December 31, 2025, Alvotech and Dr. Reddy’s announced the receipt of a Complete Response Letter (CRL) from the FDA in relation to their proposed Prolia ® / Xgeva ® biosimilar AVT03 , the aBLA for which was accepted by the FDA in March 2025. The CRL referred to observations in a pre-licensing inspection of Alvotech’s manufacturing facility and was not related to clinical efficacy or safety data for the product.
Amgen has asserted that both sets of products infringe its patents in ongoing BPCIA litigations: Boncresa™ / Oziltus™ Case No. 1:25-cv-17278 (D.N.J.) and AVT03 Case No. 1:25-cv-17277 (D.N.J.) (previously reported Amgen Files Three New Prolia ® / Xgeva ® BPCIA Litigations Against Proposed Biosimilars AVT03, MB09, and ENZ215 ).
Teva also has a pending aBLA for TVB-009P , which was accepted by the FDA in October 2024.
Amgen reported FY24 U.S. sales for Prolia ® of $2.885 billion, and $1.507 billion for Xgeva ® .
For more information on these and other biosimilars and related patent disputes, please visit BiologicsHQ.com .
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The author would like to thank April Breyer Menon for her contributions to this article.